Join us for an informative webinar as we delve into the world of psychedelic trials and the evolving regulatory landscape surrounding these transformative therapies. Explore the promising efficacy of psychedelics like psilocybin, MDMA, 5-methoxy-dimethyltryptamine, and ibogaine in treating conditions such as depression, PTSD, anxiety, and substance use disorder.
During this webinar, we will:
- Examine the diverse mechanisms of action underlying these psychedelic compounds, with a focus on serotonin 5HT2a receptor signaling.
- Discuss the important results observed in clinical trials, showcasing the potential for durable effects lasting over a year post-dosing.
- Highlight the pivotal role of organizations like MAPS (Multidisciplinary Association for Psychedelic Studies) in shaping the regulatory landscape for psychedelic medicines.
- Explore the pipeline of next-generation psychedelic medicines engineered for improved pharmacodynamic and pharmacokinetic effects, reduced toxicity, and a potential for retained efficacy without the hallucinatory aspects of current psychedelic compounds.
- Gain insights into the recent guidance issued by the US FDA and explore the regulatory pathways for the clinical study and approval of psychedelics in both Australia and the United States.
Our panel of scientists and clinicians from Australia and the US will provide invaluable insights into ongoing trials, innovations in psychedelic therapies, and the regulatory pathways shaping the future of mental health treatment.
Don’t miss this opportunity to stay informed about the latest developments in psychedelic research and regulatory advancements.
Secure your spot now for this enlightening webinar with Avance Clinical.
Speakers
Jorgen Mould, Senior Director of Scientific & Regulatory Services, Avance Clinical
Jorgen Mould is the Head of Scientific and Regulatory Affairs at Avance Clinical. Jorgen has worked within the clinical trial industry for over 25 years. Jorgen has prior experience as a Principal Scientific and Regulatory Affairs Specialist in a CRO environment. Additionally, Jorgen has prior experience in drug discovery and academic research positions at Northwestern University (USA), The University of Queensland and the Australian National University as well as 12 years in the biotechnology sector leading several ion channel/CNS drug discovery programs. Jorgen also spent four years working in medical affairs (neurology) at Merck Healthcare in Australia before joining Avance Clinical in August 2020.
Message Presenter
Kevin Leach, Senior Vice President, Scientific & Regulatory Affairs, Avance Clinical
Kevin Leach has worked broadly in the biotechnology industry with hands-on experience in early and late-stage drug discovery and development. Through positions at Merck, Shire, Retrophin, Spring Bank, Quralis and Enveric as well as several other companies through consulting interactions, Kevin has worked in and led the ADME, toxicology, pharmacology, clinical pharmacology and bioanalysis functions.
Kevin has been responsible for leading discovery and development programs, the nominations of development candidates as well as multiple regulatory filings for molecules at the IND, BLA and NDA stages. He has also been part of teams that raised funding for public and private companies and has worked at mature and very early-stage companies with experience in many different indications and molecular platforms. Kevin is a member of the Boston Psychedelic Research Group and has worked on and led teams on multiple psychedelic compounds for psychiatric indications.
Kevin has recently joined Avance Clinical, an Australian and North American biotech specialist Clinical Research Organization as Senior Vice President of Scientific and Regulatory Affairs, based in Massachusetts, USA.
Message PresenterWho Should Attend?
This webinar will appeal to VPs, Directors, Managers, Department Heads, Scientists and Researchers working within the Biotech industry in the following areas:
- Clinical affairs/Phase I unit
- Clinical R&D/research
- Clinical pharmacology/pharmacovigilance
- Clinical operations/site selection and start-up/site management organization
- Project management
- Regulatory affairs
- Medical affairs/medical research
- Bioinformatics
- Scientific affairs/study conduct
- Business operations
- Business development
What You Will Learn
Attendees will gain insights into:
- Various psychoactive substances and promising therapeutic benefits for the treatment of psychiatric conditions
- Explore the specific aspects of psychedelics crucial for orchestrating clinical trials
- Examine the regulatory landscape governing novel psychedelic clinical studies in Australia
- Delve into the outlook for emerging psychedelic compounds and their potential impact on the future
Xtalks Partner
Avance Clinical
Avance Clinical is a full-service CRO for biotechs with a proven track-record for delivering clinical excellence in Australia, New Zealand, and North America. As the largest premium full-service CRO in Australia and North America, Avance Clinical specializes in delivering top-tier clinical trials that yield globally accepted data.
Pre-clinical through to Phase I and Beyond
Avance Clinical offers pre-clinical consultancy services with their experienced ClinicReady team right through to Phase I and beyond clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes that are available in Australia. With experience across more than 110 therapeutic indications, Avance Clinical can deliver world-class, high-quality, internationally accepted data suitable for FDA and EMA review.
Avance Clinical uses state-of-the-art technology and gold-standard systems across all functional areas to provide clients with the most effective processes.
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